A Randomized Open Label Controlled Clinical Study To Evaluate The Efficacy Of Kuberaksh Vati And Rajaparvartini Vati In The Management Of Udavartini Yonivyapad W.S.R. Primary Dysmenorrhoea.
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Change In The Grade Of VAS Visual Analogue Score Scale Of Pain
研究概览
简要总结
PRIMARY DYSMENORRHOEA IS PAINFUL MENSTRUAL CRAMP ORIGINATING IN THE LOWER ABDOMEN COMMONLY EXPERIENCED BEFORE OR DURING MENSTRUATION WHICH AFFECTS DAY TO DAY ACTIVITES. PRIMARY DYSMENORRHOEA IS NOT ASSOCIATED WITH ANY PELVIC PATHOLOGY. IN AYURVEDA IT CAN BE CORRELATED WITH UDAVARTINI YONIVYAPAD.
IN UDAVARTINI YONIVYAPAD DOSHA INVOLVEMENT OF VATA. VATA IS A SIGN OF PAIN AND ALL GYNACOLOGICAL DISEASE OCCUR DUE TO APANA VATA DUSHTI.
PATIENTS WITH PRIMARY DYSMENORRHOEA WILL BE REGISTERED IN 2 GROUPS (30 IN EACH GROUP).
GROUP A GIVEN KUBERAKSH VATI AND GROUP B RAJAPARVARTINI VATI ON 7 DAYS BEFORE EXPECTED DATE OF MENSES FOR 10 DAYS.
PAIN ASSESMENT OF DYSMENORRHOEA DONE BY VAS SCALE (1-10 SCORE)
AT THE LAST OF TRIAL OBSERVE CHANGE IN THE GRADE OF VAS SCALE PAIN.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- None
入排标准
- 年龄范围
- 16.00 Year(s) 至 35.00 Year(s)（—）
- 性别
- Female
入选标准
- •Patient Willing To Give Voluntary Informed Consent Age Group Between 16-35 Years Both Married And Unmarried Women Pain In The Lower Abdomen Which Begin One Or Two Days Before Menstruation Or With The Onset Of Menstruation And Lasting For Few Hours Or One To Two Days Painful Menstruation Also Associated With Symptoms Like Nausea Vomiting Constipation Etc History Of Painful Menstruation For Atleast 3 Consecutive Cycles Patient Diagnosed With Dysmenorrhoea Patient With Regular Menstrual Cycle 21 To 35 Days.
排除标准
- •Patient Who Is Not Willing To Give Voluntary Informed Consent Patients Taking Any Hormonal Therapy Patients Of Any Pelvic Pathology PCOD PID Cervical stenosis Fibroid Endometriosis Adenomyosis Etc Patients With Congenital Anomalies Of Reproductive System Other Medical Disorders Which Make Patients At High Risk Like Epilepsy Anaemia Hb Less Than 8mg/dl Heart Disease DM Surgical And Malignant Conditions Heavy Bleeding During Menses Patients Are Excluded More Than 4 Pads Fully Soaked Per Day.
结局指标
主要结局
Change In The Grade Of VAS Visual Analogue Score Scale Of Pain
时间窗: Follow Up Will Be Done on Day 4 Of Three Consecutive Cycles And 120th day
次要结局
- CHANGES IN OTHER ASSOCIATED CLINICAL SYMPTOMS LIKE NAUSEA VOMITING ETC(Follow Up Will Be Done On Day 4 Of Three Consecutive Cycles And 120th day)
研究者
Dr Manju
Institute For Ayurved Studies And Research